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Shweta Kamble

Shweta Kamble

Clinical Research Coordinator

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location of Shweta KambleBangaluru, Karnataka, Indie

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  • Timeline

  • About me

    Senior Data Manager at Novo Nordisk

  • Education

    • Somalwar High school, Nagpur

      -
      High school SSC

      Completed 1 to 10 Education High school

    • Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU)

      -
      Master of Science (MSc) Biotechnology I grade

      Project workMolecular detection of Cytomegalovirus (CMV) in pregnant women referred for the Triple Marker Test, at R&D Department, Molecular Diagnostic, Religare SRL (formerly SRL Ranbaxy), Andheri, Mumbai, 2007 Scientific Techniques such as Polymerase Chain Reaction (PCR), ELISA, DNA extraction, Gel electrophoresis were carried out. Conducted routine experiments and completed literature review related to research project and summarized results for abstract

  • Experience

    • Government Medical College & Hospital

      Jan 2009 - Jan 2010
      Clinical Research Coordinator

    • Cegedim

      Jan 2010 - Jan 2012
      Jr Research analyst

      Responsible for collecting/ evaluating information for Pharmaceutical brands, molecules under clinical trial, Pharmaceutical companies (International and local pharma companies) from diverse web resources by using different tools and databases for 40 Countries (Google search, official database of various countries, company websites, online translator, Martindale etc..) Analyzing qualitative and quantitative parameters to support, review new and existing pharmaceutical brands, performing modification, quality checks in database Worked on KOL mapping (Key operating leaders):- Secondary Research using web-based tools Google Scholar, Pub-Med to search publications and research works for KOLs Quality Control:-Maintained quality standards and improvised quality system, Responsible for data cleaning, data editing, data matching Pokaż mniej

    • Central India Cancer Research Institute

      Jan 2012 - Jan 2013
      Clinical Research Coordinator

      Therapeutic area of clinical trial worked: - Oncology, PsychiatryCoordinate Phase I, Phase III, Phase IV-Post marketing trial. Responsible for collection, tracking of clinical data and resolution of data queries, maintain source document of patients, CRF, ECRF completion, Safety/SAE reporting, data management, all process were performed in compliance with standard GCP, Good understanding of ICH-GCP guidelines, Pharmacovigilance other practical aspects of Clinical Trials, Familiar with medical terminologies ,Good electronic medical/research data input, capture, Recording, and Transmission Pokaż mniej

    • PharmEDGE

      Jan 2013 - Jan 2014
      Medical Research Associate

      • Medical writing (Scientific writing) preparation of manuscripts, articles, poster and report publications• Assist in conducting observational Patient report outcome (PRO) “Quality of Life” studies across various therapeutic areas, designing study protocols, ICFs, coordinating with study PIs, and conducting patient interviews using pre-developed surveys.• Linguistic validation studies.

    • Cognizant Technology Solutions

      Jan 2014 - Jan 2018
      Clinical Data Analyst

      • Working for CDM Process for oncology study (conduct phase).• Working on clinical Platform Inform, Rave.• Perform various data management activities as data validation, discrepancy management, UAT, report preparations, • Quality Control: - Maintained quality standards and improvised quality system, Responsible for data cleaning

    • ICON plc

      Jan 2018 - Jan 2020

      • Working on Observational (Non interventional studies), Real world evidence (RWE) studies.• Responsible for DM activities for assigned projects from project start up to close out. Designs Electronic Data Capture (EDC) databases to collect and process CRF data; may include coordination with EDC vendors and programmers to deliver a validated system. Preforms UATfor EDC and edit check review. Develops specifications for standard edit checks, data listings, and reports. Generates standard and ad hoc reports of EDC CRF or metric data for study team and management reporting. Prepare study guidelines for data entry, EDC completion guidelines.• Worked with study lead for building, development and finalization of online surveys with Confirmit tool. Pokaż mniej

      • Data Management Team Lead

        Jan 2020 - Jan 2020

      • Senior Clinical Data Coordinator

        Jan 2018 - Mar 2020

    • Novo Nordisk

      Jan 2020 - Jan 2024
      Senior Data Manager

  • Licenses & Certifications